D.THERAPINO ONE STEP HAND SANITIZER- alcohol gel 
David Cosmetic Co Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

ethanol

Alcohol
Water
Carbomer
Aloe Barbadensis Leaf Extract
Water
Butylene Glycol
1,2-Hexanediol
Triethanolamine
Menthol

hand sanitizer to help reduce bacteria that potentially can cause disease

for use when soap and water are not available

KEEP OUT OF REACH OF THE CHILDREN

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

for external use only

label

D.THERAPINO ONE STEP HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58241-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58241-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
2NDC:58241-0001-2300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
3NDC:58241-0001-380 mL in 1 TUBE; Type 0: Not a Combination Product03/21/2020
4NDC:58241-0001-450 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2020
5NDC:58241-0001-5100 mL in 1 TUBE; Type 0: Not a Combination Product04/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/21/2020
Labeler - David Cosmetic Co Ltd (695697845)
Registrant - David Cosmetic Co Ltd (695697845)
Establishment
NameAddressID/FEIBusiness Operations
David Cosmetic Co Ltd695697845manufacture(58241-0001) , label(58241-0001)

Revised: 4/2020
Document Id: a41a9716-b375-18b4-e053-2995a90a041e
Set id: a198af1a-17fb-7489-e053-2995a90a00aa
Version: 2
Effective Time: 20200425
 
David Cosmetic Co Ltd